Study of Amoxicillin and Metronidazole or Azithromycin to Improve Periodontal Treatment Outcomes Pharmacokinetics and Dosing in Adults with Severe Gum Disease

What this Trial Is About

Researchers are evaluating the use of antibiotics as additional treatments alongside mechanical cleaning for patients with severe periodontitis, an inflammatory disease that damages tooth-supporting tissues and can lead to tooth loss. This trial focuses on how two antibiotic regimensamoxicillin plus metronidazole and azithromycinare absorbed and act in the body to optimize dosage and duration while minimizing risks of antibiotic resistance. The study is a randomized, single-blind clinical trial involving 45 patients over 44 months at the University of Geneva. Participants receive standard mechanical cleaning of their teeth in two appointments, followed by one of three antibiotic treatments amoxicillin plus metronidazole taken three times daily for either 7 days or 3 days, or azithromycin taken once daily for 3 days. Clinical samples such as gingival fluid, saliva, blood, and plaque are collected at various points during and after treatment to measure antibiotic levels and effects on bacteria. The study also monitors safety and adverse events throughout. Throughout the approximately 8-month participation, patients undergo clinical and radiographic exams, sample collection, and follow-up visits at 3 and 6 months to assess bacterial presence and treatment success. Researchers track patient compliance and record any adverse effects. The primary outcome is measuring antibiotic concentrations in bodily fluids at specific days after dosing, while secondary outcomes include changes in bacteria levels, clinical improvements, and safety assessments.

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies